FDA to Review Lymphoseek sNDA in Head and Neck Cancer

Navidea Biopharmaceuticals announced that the FDA has accepted its Supplemental New Drug Application (sNDA) and granted it Priority Review for the expanded use of Lymphoseek (technetium 99m tilmanocept) Injection for sentinel lymph node (SNL) detection in patients with head and neck cancer. Lymphoseek Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer.

The sNDA submission included data from the NEO3-06 Phase 3 study that showed with statistical significance the ability of Lymphoseek to correctly identify patients with pathology-positive lymph nodes compared with multiple level lymph node dissection and pathology assessment. NEO3-06 was a prospective, open-label, multicenter, within-patient study designed to identify sentinel lymph nodes and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma. The primary endpoint for the NEO3-06 trial was based on the number of subjects with pathology-positive lymph nodes following a multiple level lymph node dissection and required a minimum of 38 subjects whose lymph nodes contained pathology-confirmed disease.

A total of 39 out of 80 subjects enrolled in the NEO3-06 trial were determined to have pathology-positive lymph nodes. Results demonstrated that Lymphoseek correctly identified 38 of these 39 patients, for an overall FNR of 2.56%, which met the predefined statistical threshold. Moreover, multiple level nodal dissection of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing single lymph node biopsy.